GRAS (Generally Recognized as Safe)

GRAS is a designation under the Federal Food, Drug, and Cosmetic Act meaning a substance is generally recognized as safe for its intended use by qualified experts. GRAS can be self-affirmed (company's own experts determine safety without FDA notification) or FDA-notified (company submits a GRAS notice to FDA and receives a 'no questions' response letter). FDA-notified GRAS provides stronger transparency because it creates a public notice, public dossier trail, and FDA response. Self-affirmed GRAS with a rigorous public dossier and properly constructed independent expert panel can still be meaningful evidence. FDA's own guidance says its scientific recommendations apply whether or not a GRAS conclusion is submitted. For dietary supplement ingredients, GRAS is often not the primary legal question; the relevant legal routes are typically NDI notification (post-1994 ingredients), documented pre-1994 marketing history, or food-supply presence in unaltered form. CONFIRMED: HHS Secretary Kennedy directed FDA on March 10, 2025 to explore rulemaking to eliminate self-affirmed GRAS (source: HHS.gov press release). FDA's Fall 2025 Unified Agenda included a proposed rule requiring mandatory GRAS notice submission. Legislative alternative: S. 3122 (Marshall, Nov 2025). Status as of April 2026: UNCERTAIN whether the proposed rule has been published in the Federal Register (delayed by government shutdown). If finalized, this would end the self-affirmation pathway.